BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PULS

    MDR report key: 1153076 · Received September 8, 2008

    Report

    Report Number
    3005113652-2008-00055
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    July 11, 2008
    Report Date
    August 14, 2008
    Manufacturer
    PRINGY
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON 09/08/2008.

    Description of Event or Problem · 1

    IMMEDIATELY AFTER TREATMENT WITH JUVEDERM ULTRA PLUS IN THE GLABELLA, AND BETWEEN THE NOSE AND OUTER EDGE OF THE MOUTH, THE PT EXPERIENCED BRUISING AND SWELLING IN THE CHEEKS (BELOW THE EYES TO THE JOWLS). THE BRUISING RESOLVED WITHIN 10 DAYS WITHOUT ANY INTERVENTION. RECENT F/U FROM THE PHYSICIAN NOTES THAT THE PT CONTACTED THE PHYSICIAN VIA PHONE APPROX 18 DAYS POST TREATMENT. THE PHYSICIAN RECOMMENDED COLD COMPRESSES TO THE SWELLING AND PRESCRIBED BENADRYL (OTC). THE PT CONTACTED THE PHYSICIAN AGAIN AT 21 DAYS POST TREATMENT AND THE PHYSICIAN STATES THAT A MEDROL DOSEPAK WAS PRESCRIBED FOR THE SWELLING. THE PHYSICIAN NOTES THAT THE PT REVEALED RETIN-A WAS BEING USED AND THE PHYSICIAN RECOMMENDED TO THE PT THAT RETIN-A NOT BE USED. THE PHYSICIAN STATED THAT THERE WAS NO WAY OF KNOWING IF PERMANENT DAMAGE WOULD HAVE OCCURRED OR NOT HAD TREATMENT NOT BEEN PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUVEDERM ULTRA PULS JUVEDERM LMH PRINGY NA HV30471056

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention RETIN-A